post-title portfolio-title Levothyroxine Tablets IP 25mcg, 50mcg, 100mcg, 125mcg (Thyrosec) Taj Pharma 2020-02-24 11:48:01 no no

Levothyroxine Tablets IP 25mcg, 50mcg, 100mcg, 125mcg (Thyrosec) Taj Pharma

Levothyroxine Tablets IP 25mcg, 50mcg, 100mcg, 125mcg (Thyrosec) Taj Pharma

INFORMATION ABOUT THYROXINE/LEVOTHYROXINE

Thyroxine/levothyroxine uses

Thyroxine/Levothyroxine is used in the treatment of?hypothyroidism.

How thyroxine/levothyroxine works

Thyroxine/Levothyroxine is a synthetic version of a hormone produced by the thyroid gland. It works by replacing the thyroid hormones that your thyroid gland cannot produce and relieves the symptoms of hypothyroidism (tiredness, weight gain, and depression).

Common side effects of thyroxine/levothyroxine

Anxiety, Vomiting, Diarrhea, Palpitations, Nervousness, Weight loss, Flushing (sense of warmth in the face, ears, neck and trunk), Restlessness

EXPERT ADVICE FOR THYROXINE/LEVOTHYROXINE

  • Thyroxine/Levothyroxine should be taken on an empty stomach (ideally, first thing in the morning). No food, milk, or tea should be taken 1 hour before and 2 hours after taking this medicine.
  • It may take 6 to 8 weeks to get the full effect.
  • For most people, Thyroxine/Levothyroxine can be a lifelong medication. Do not discontinue it without discussing your doctor.
  • Inform your doctor if you have diarrhea, nervousness, irritability, sleep disturbances, shaking hands, or chest pain. Your doctor may adjust your dose.
  • Leave a gap of at least 4 hours before taking any antacids, calcium or iron supplements, and multivitamins, as these may interfere with the effect of the medicine.
  • Get your hormone levels checked regularly and inform your doctor if you notice a significant change in your body weight. The dose may need to be adjusted.
  • Inform your doctor before changing the brand of Thyroxine/Levothyroxine as all brands may not have the same effect.

FREQUENTLY ASKED QUESTIONS FOR THYROXINE/LEVOTHYROXINE

Thyroxine/Levothyroxine

Q. How should Thyroxine/Levothyroxine be taken?

Take Thyroxine/Levothyroxine exactly as advised by your doctor. Thyroxine/Levothyroxine should be taken orally preferably before breakfast or as a first meal of the day. It should be swallowed whole with plenty of water.
Q. What should I do if I accidentally take more than the dose required?
An overdose of this medicine may cause nervousness, anxiety, rapid heartbeat, hand tremors, excessive sweating, weight loss, and sleep problems. You should immediately consult your doctor in case of an overdose.

Q. How long do I need to take Thyroxine/Levothyroxine?

You should take Thyroxine/Levothyroxine as long as your doctor has recommended. Usually, it is prescribed for long term and you may have to take it life long. Do not stop taking the medicine, as your symptoms of low levels of thyroid hormone may reoccur.

Q. Being a diabetic what should I be aware of while taking Thyroxine/Levothyroxine?

Thyroxine/Levothyroxine may raise blood sugar levels and may affect the working of other anti-diabetic medicines which you might be taking. Hence, dose adjustment may be required. Consult your doctor who will help you with dose management.

Q. Does Thyroxine/Levothyroxine affect contraception?

Oral birth control pills, which contain both estrogen and progesterone may reduce the amount of Thyroxine/Levothyroxine in your body and therefore the dose of Thyroxine/Levothyroxine may have to be increased.

Q. What are the side effects of taking Thyroxine/Levothyroxine?

The side effects of Thyroxine/Levothyroxine are mostly seen when it is taken at high doses. These symptoms include allergic reaction, headache, vomiting, flushing, high temperature, sweating, weight loss, tremor, restlessness, and excitability. It may also cause difficulty in sleeping (insomnia), increased pressure around the brain in children (benign intracranial hypertension), chest pain (angina), pounding, irregular or fast heartbeat, diarrhea, muscle cramps, and muscle weakness. The other side effects related to Thyroxine/Levothyroxine include deformity of the skull in infants caused by the early closure of joints in the skull bone (craniostenosis), growth in children may slow or stop due to changes in bone growth, irregular periods, intolerance to heat, and temporary hair loss in children.

Q. What does thyroxine do? Why is it important?

Thyroxine hormone controls how much energy your body uses. It plays an important role in regulating your body weight, muscle strength, body temperature, and even your mood. Along with that, it is important for your digestion, heart muscles, brain development, and bone health.

Levothyroxine Tablets IP 25mcg, 50mcg, 100mcg, 125mcg (Thyrosec) Taj Pharma

1. NAME OF THE MEDICINAL PRODUCT
a) Levothyroxine Tablets IP 25mcg Taj Pharma
b) Levothyroxine Tablets IP 50mcg Taj Pharma
c) Levothyroxine Tablets IP 100mcg Taj Pharma
d) Levothyroxine Tablets IP 125mcg Taj Pharma

2.QUALITATIVE AND QUANTITATIVE COMPOSITION??????????????????????????????

a) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 25mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

b) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 50mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

c) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 100mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

d) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 125mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

For the full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM
Tablet.

White uncoated biconvex tablets

4.CLINICAL PARTICULARS

4.1 Therapeutic indications

Recommended clinical indications: Control of hypothyroidism, congenital hypothyroidism in infants, acquired hypothyroidism in children and juvenile myxoedema.

4.2 Posology and method of administration

Posology

In younger patients, and in the absence of heart disease, a serum Levothyroxine (T4) level of 70 to 160 nanomols per litre, or a serum thyrotrophin level of less that 5 milli-units per litre should be targeted.

A pre-therapy ECG is valuable because ECG changes due to hypothyroidism may be confused with ECG evidence of cardiac ischaemia. If too rapid an increase in metabolism is produced (causing diarrhoea, nervousness, rapid pulse, insomnia, tremors, and sometimes anginal pain where there is latent cardiac ischaemia), dosage must be reduced, or withheld, for a day or two, and then re-started at a lower dose level.

Adults: Initially 50 to 100 micrograms daily, preferably taken before breakfast or the first meal of the day. Adjust at three to four week intervals by 50 micrograms until normal metabolism is steadily maintained. The final daily dose may be up to 100 to 200 micrograms.

Elderly:?As for patients aged over 50 years.

For patients over 50 years, initially, it is not advisable to exceed 50 micrograms daily. In this condition, the daily dose may be increased by 50 micrograms at intervals of every 3-4 weeks, until stable thyroxine levels are attained. The final daily dose may be up to 50 to 200 micrograms.

Patients over 50 years with cardiac disease:

Where there is cardiac disease, 25 micrograms daily or 50 micrograms on alternate days is more suitable. In this conditions, the daily dose may be increased by 25 micrograms at intervals of every 4 weeks, until stable thyroxine levels are attained. The final daily dose may be up to 50 to 200 micrograms.

For patients aged over 50 years, with or without cardiac disease, clinical response is probably a more acceptable criteria of dosage rather that serum levels.

Paediatric population:

The maintenance dose is generally 100 to 150 micrograms per m? body surface area. The dose for children depends on their age, weight and the condition being treated. Regular monitoring using serum TSH levels, as in adults, is required to make sure he/she gets the right dose. Infants should be given the total daily dose at least half an hour before the first meal of the day.

Congenital hypothyroidism in infants:

For neonates and infants with congenital hypothyroidism, where rapid replacement is important, the initial recommended dosage is 10 to 15 micrograms per kg BW per day for the first 3 months. Thereafter, the dose should be adjusted individually according to the clinical findings and thyroid hormone and TSH values.

Acquired hypothyroidism in children:

For children with acquired hypothyroidism, the initial recommended dosage is 12.5-50 micrograms per day. The dose should be increased gradually every 2 – 4 weeks according to the clinical findings and thyroid hormone and TSH values until the full replacement dose is reached

Juvenile myxoedema in children:

The initial recommended dosage is 25 micrograms daily. In such conditions, the daily dose may be increased by 25 micrograms at intervals of every 2 – 4 weeks, until mild symptoms of hyperthyroidism is seen. The dose will then be reduced slightly.

In children under 5 years of age, the administration of whole tablets is not recommended. It is also not recommended that tablets are crushed and dispersed in water or other liquids, owing to limited solubility which could lead to dosing inaccuracy. In this age group it is preferable to administer an approved oral solution of levothyroxine.

Method of administration

Oral

4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Thyrotoxicosis.
  • Adrenal gland disorder or adrenal insufficiency.

4.4 Special warnings and precautions for use

Patients with panhypopituitarism or other causes predisposing to adrenal insufficiency may react to levothyroxine treatment, and it is advisable to start corticosteroid therapy before giving levothyroxine to such patients.

In individuals suspected to have cardiovascular disease or to be at high risk, it is important to perform an ECG prior to commencement of levothyroxine treatment in order to detect changes consistent with ischaemia in which case, levothyroxine should be initiated at a low dose, followed by cautious dose escalation to avoid worsening of ischaemia or precipitation of an infarct.

Special care is needed for the elderly and for patients with symptoms of myocardial insufficiency, or ECG evidence of myocardial infarction.

Levothyroxine sodium should be used with caution in patients with cardiovascular disorders, including angina, coronary artery disease and hypertension, and in the elderly who have a greater likelihood of occult cardiac disease.

To minimise the risk of adverse effects of undetected overtreatment, such as atrial fibrillation and fractures associated with low serum levels of thyroid stimulating hormone (TSH) in older patients, it is important to monitor serum TSH and adjust the dose accordingly during long term use

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Levothyroxine should be introduced very gradually in patients aged over 50 years (See section 4.2) and those with long standing hypothyroidism to avoid any sudden increase in metabolic demands.

Thyroid replacement therapy may cause an increase in dosage requirements of insulin or other anti-diabetic therapy (such as metformin). Care is needed for patients with diabetes mellitus and diabetes insipidus.

See note above regarding withdrawal of treatment.

Parents of children receiving thyroid agent should be advised that partial loss of hair may occur during the first few months of therapy, but this effect is usually transient and subsequent regrowth usually occurs.

Care is required when levothyroxine is administered to patients with known history of epilepsy. Seizures have been reported rarely in association with the initiation of levothyroxine sodium therapy, and may be related to the effect of thyroid hormone on seizure threshold.

Subclinical hyperthyroidism may be associated with bone loss. To minimise the risk of osteoporosis, dosage of levothyroxine sodium should be titrated to the lowest possible effective level.

Haemodynamic parameters should be monitored when levothyroxine therapy is initiated in very low birth weight preterm neonates as circulatory collapse may occur due to the immature adrenal function.

4.5 Interaction with other medicinal products and other forms of interaction

Interactions affecting other drugs:

Anticoagulants (Warfarin): Levothyroxine increases the effect of anticoagulants?and it may be necessary to reduce the anticoagulation dosage if excessive, hypoprothrombinaemia and bleeding are to be avoided

Antidiabetics: Blood sugar levels are raised and dosage of anti-diabetic agents may require adjustment.

Antidepressant: Levothyroxine increases receptor sensitivity to catecholamines thus accelerating the response to tricyclic antidepressants (e.g. amitriptyline, imipramine, dosulepin).

Sympathomimetics: The effects of sympathomimetic agents (e.g. adrenaline or phenylephrine) are also enhanced.

Cardiac glycosides: If levothyroxine therapy is initiated in digitalised patients, the dose of digitalis may require adjustment. Hyperthyroid patients may need their digoxin dosage gradually increased as treatment proceeds because initially patients are relatively sensitive to digoxin.

NSAIDs: False low plasma concentrations have been observed with concurrent anti-inflammatory treatment such as phenylbutazone or acetylsalicylic acid and levothyroxine therapy.

Beta Blockers: levothyroxine (thyroxine) accelerates metabolism of propranolol, atenolol and sotalol.

General anaesthetics: Isolated reports of marked hypertension and tachycardia have been reported with concurrent ketamine administration.

Interactions affecting Levothyroxine:

Anti arrhythmics: Amiodarone may inhibit the de iodination of thyroxine to tri iodothyronine resulting in a decreased concentration of tri iodothyronine, thereby reducing the effects of thyroid hormones.

Anti-convulsants, such as carbamazepine, primidone and phenytoin, enhance the metabolism of thyroid hormones and increase requirement for thyroid hormones in hypothyroidism.

Effects of Levothyroxine may be decreased by concomitant sertraline.

Antineoplastics: plasma concentration of levothyroxine (thyroxine) possibly reduced by imatinib.

Sex Hormones: Oestrogen, oestrogen containing product (including hormone replacement therapy) and oral contraceptives may increase the requirement of thyroid therapy dosage. Conversely, androgens and corticosteroids may decrease serum concentrations of Levothyroxine-binding globulins.

Lipid regulating drugs: Lovastatin has been reported to cause one case each of hypothyroidism and hyperthyroidism in two patients taking levothyroxine.

Beta blockers may decrease the peripheral conversion of levothyroxine to triiodothyronine.

Metabolism of levothyroxine (thyroxine) accelerated by rifampicin, barbituarates (may increase requirements for levothyroxine (thyroxine) in hypothyroidism)

Absorption of levothyroxine (thyroxine) possibly reduced by antacids, proton pump inhibitors, calcium salts, cimetidine, oral iron, sucralfate, colestipol, polystyrene sulphonate resin and cholestyramine (administration should be separated by 4-5 hours).

Anti-obesity drugs such as orlistat may decrease levothyroxine absorption which may result in hypothyroidism (monitor for changes in thyroid function).

A number of drugs may affect thyroid function tests and this should be borne in mind when monitoring a patient on levothyroxine therapy.

Post-marketing cases have been reported indicating a potential interaction between ritonavir containing products and levothyroxine. Thyroid-stimulating hormone (TSH) should be monitored in patients treated with levothyroxine at least the first month after starting and/or ending ritonavir treatment.

4.6 Fertility, pregnancy and lactation

Pregnancy

The safety of Levothyroxine treatment during pregnancy is not known, but any possible risk of foetal abnormalities should be weighed against the risk to the foetus of untreated hypothyroidism.

Breast-feeding

Levothyroxine is excreted in breast milk in low concentrations, and it is contentious whether this can interfere with neonatal screening.

4.7 Effects on ability to drive and use machines

Levothyroxine has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Side-effects are usually indicative of excessive dosage and usually disappear on reduction of dosage or withdrawal of treatment for a few days.

Adverse reactions listed below have been observed during clinical studies and/or during marketed use and are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention:

Not known (cannot be estimated from the available data)

System organ classFrequencyUndesirable effects
Immune system disordersNot knownHypersensitivity reaction,
Endocrine disordersNot knownThyrotoxic crisis1
Psychiatric disordersNot knownRestlessness, agitation, insomnia, convulsions2
Nervous system disordersNot knownTremor,
Cardiac disordersNot knownAngina pectoris, arrhythmia, palpitations, tachycardia
Vascular disordersNot knownFlushing,
Respiratory, thoracic and mediastinal disordersNot knownDyspnoea
Gastrointestinal disordersNot knownDiarrhoea, vomiting
Skin and subcutaneous tissue disordersNot knownHyperhidrosis, rash, pruritus
Musculoskeletal and connective tissue disorderNot knownArthralgia, muscle spasm, muscular weakness,
Reproductive system disordersNot knownMenstruation irregular
General disorders and administration site conditionsNot knownHeadache, pyrexia, malaise, oedema
InvestigationsNot knownWeight decreased

1Some patients may experience a severe reaction to high levels of thyroid hormone. This is called a “thyroid crisis” with any of the following symptoms: Hyperpyrexia, tachycardia, arrhythmia, hypotension, cardiac failure, jaundice, confusion, seizure and coma

2Especially in patients with known history of epilepsy

Paediatric population

Heat intolerance, transient hair loss, benign intracranial hypertension, craniostenosis in infants and premature closure of epiphysis in children.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms

In most cases there will be no features. Signs of an overdose may include: fever, chest pain (angina), racing or irregular heartbeat, muscle cramps, headache, restlessness, flushing, sweating, diarrhoea, tremor, insomnia and hyperpyrexia. These signs can take up to 5 days to appear. Atrial fibrillation may develop. Convulsions occurred in one child. There may be increased toxicity in those with pre-existing heart disease.

Management:

Give oral activated charcoal if more than10mg has been ingested by an adult or more than 5mg by a child, within 1 hour. If more than 10mg has been ingested by an adult or more than 5mg by a child, take blood 6-12 hours after ingestion for measurement of the free thyroxine concentration. The analysis does not need to be done urgently but can wait until the first working day after the incident. Patients with normal free thyroxine concentrations do not require follow up. Those with high concentrations should have outpatient review 3-6 days after ingestion to detect delayed onset hyperthyroidism. Features of clinical hyperthyroidism should be controlled with beta-blockers, e.g. propranolol

5.PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Thyroid hormones

Levothyroxine 50 micrograms Tablets are tablets containing Levothyroxine sodium used for the treatment of hypothyroidism. The Thyroid gland is dependent upon 2 active principles for its main hormone activity. These are Levothyroxine (Tetraiodothyronine) and Tri-iodothyronine (see Goodman and Gilman, 1985). These closely related iodine containing amino acids are incorporated into the glycoprotein thyroglobulin. Levothyroxine is deiodinated in peripheral tissues to form triiodothyronine which is thought to be the active tissue form of thyroid hormone. Triiodothyronine has a rapid action but a shorter duration of activity than Levothyroxine.

The chief action of Levothyroxine is to increase the rate of cell metabolism.

5.2 Pharmacokinetic properties

Levothyroxine sodium is incompletely and variably absorbed from the gastrointestinal tract. It is almost completely bound to plasma proteins and has a half-life in the circulation of about a week in healthy subjects, but longer in patients with myxoedema.

A large portion of the Levothyroxine leaving the circulation is taken up by the liver. Part of a dose of Levothyroxine is metabolised to triiodothyronine. Levothyroxine is excreted in the urine as free drug, deiodinated metabolites and conjugates. Some Levothyroxine is excreted in the faeces. There is limited placental transfer of Levothyroxine.

5.3 Preclinical safety data

No further data of relevance.

6.PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium Citrate

Lactose

Maize starch

Powdered Acacia

Magnesium Stearate

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months for polypropylene containers.

24 months for blister packs.

6.4 Special precautions for storage

Do not store above 25?C. Store in the original package in order to protect from light and moisture.

6.5 Nature and contents of container

Polypropylene container with tamper-evident low density polyethylene lid, containing 28, 56,100, 112 or 1000 Levothyroxine l00microgram tablets.

Blister packaging PVC/PVdC film (heat treated foil/heat seal lacquer) containing 28, 56 and 112 Levothyroxine tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
Survey No.188/1 to 189/1,190/1 to 4,
Athiyawad, Dabhel,
Daman- 396210 (INDIA)

Levothyroxine Tablets IP 25mcg, 50mcg, 100mcg, 125mcg (Thyrosec) Taj Pharma
Package leaflet: Information for the patient

Levothyroxine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read itagain.
  • If you have any further questions, ask your doctor orpharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harmthem, even if their signs of illness are the same asyours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section4.

What is in this leaflet:

  1. What Levothyroxine is and what it is used for
  2. What you need to know before you take Levothyroxine
  3. How to take Levothyroxine
  4. Possible side effects
  5. How to store Levothyroxine
  6. Contents of the pack and other information
1 WHAT LEVOTHYROXINE IS AND WHAT IT IS USED FOR

Thyroxine is a hormone which is produced naturally in the body by the thyroid gland. Levothyroxine is a synthetic version of this hormone. Thyroxine controls how much energy your body uses. When the thyroid gland does not produce enough thyroxine (a condition known as hypothyroidism), many of the body?s functions slow down. Some of the most common symptoms of hypothyroidism are:
? tiredness
? weight gain
? feeling depressed

Levothyroxine tablets are used to replace the thyroxine that your thyroid gland cannot produce and prevent the symptoms of hypothyroidism. Before starting your treatment your doctor will carry out a blood test to work out how much levothyroxine you need.

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVOTHYROXINE

Do not take Levothyroxine Tablets:
? if you are allergic to levothyroxine or any of the other ingredients of this medicine (listed in section 6)
? if you suffer from an overactive thyroid gland that produces too much thyroid hormone (thyrotoxicosis)
? if you have any condition that affects your adrenal glands (your doctor will be able to advise you if you are not sure).

If any of these apply to you, do not take this medicine and go back to your doctor to discuss your treatment.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Levothyroxine Tablets
? if you have suffered with an under active thyroid gland for a long time
? if you suffer from heart problems including angina, coronary artery disease or high blood pressure
? if you are being treated for diabetes. The dose of your antidiabetic medicine may need to be changed as levothyroxine can raise blood sugar levels
? if you are over 50 years of age.

Blood pressure will be regularly monitored when levothyroxine treatment is started in very low birth weight preterm neonates because rapid fall in blood pressure (known as circulatory collapse) may occur.

Blood tests
Before you start taking levothyroxine your doctor will do a blood test to see how much thyroxine your thyroid gland is making and what dose of the medicine you will need. Once you start taking the medicine your doctor will want you to have regular blood tests to see how well the medicine is working.

Other medicines and Levothyroxine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over the counter medicines, herbal remedies and vitamin supplements. Many medicines affect the way levothyroxine works. The effects of other drugs may also be affected by levothyroxine.

The following may affect the way that levothyroxine works:
? medicines for epilepsy such as carbamazepine, phenytoin, primidone and barbiturates
? sertraline ? used to treat depression and anxiety disorders
? antacids ? used to treat indigestion
? medicines containing calcium salts
? cimetidine ? used to reduce excess stomach acid
? proton pump inhibitors such as omeprazole, lansoprazole and pantoprazole – used to reduce the amount of acid produced by the stomach
? sucralfate ? used to treat and prevent stomach and duodenal ulcers
? cholestyramine and colestipol ? used to treat high level of fat in the blood
? polystyrene sulphone resin ? used to reduce high levels of potassium in the blood
? medicines containing iron that are taken by mouth
? rifampicin ? used to treat infections
? imatinib ? used to treat certain types of cancer
? beta blockers such as atenolol and sotalol ? used to treat high blood pressure and heart problems
? oestrogen containing medicines for hormone replacement therapy (HRT) and contraception (the ?pill?)
? androgen containing medicines for male hormone replacement therapy
? corticosteroids such as hydrocortisone and prednisolone ? used to treat inflammation
? amiodarone ? used to treat an irregular heart beat
? orlistat ? used to treat obesity
? ritonavir ? used to control HIV and chronic hepatitis C virus.

The following may be affected by levothyroxine:
? anticoagulant medicines to prevent blood clots such as warfarin
? medicines to treat diabetes such as insulin and metformin
? tricyclic antidepressants such as amitriptyline, imipramine and dosulepin
? medicines that stimulate the sympathetic nervous system such as adrenaline (used to treat severe allergic reactions) or phenylephrine (a decongestant found in many cold and flu treatments)
? digoxin ? used to treat heart problems
? anti-inflammatory medicines such as phenylbutazone or aspirin
? propanolol ? used to treat high blood pressure and heart problems
? ketamine ? used as an anaesthetic. If you need to have an operation, please tell your doctor or anaesthetist that you are taking levothyroxine.

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you should continue treatment with levothyroxine whilst you are pregnant, particularly in the first three months of your pregnancy.

Driving and using machines:
This medicine should not affect your ability to drive and use machines.

Levothyroxine Tablets contain lactose:
This medicine also contains lactose, a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 HOW TO TAKE LEVOTHYROXINE

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You may be taking this medicine for the rest of your life.

Your dose will be decided by your doctor and will depend on the results of your blood tests. The dose you should take will be on the label attached by your pharmacist. Swallow the tablets with plenty of water. You should usually take your tablets before breakfast or your first meal of the day.

Adults:
The recommended starting dose is 50 – 100 micrograms every day. Your doctor may increase the dose you take every 3-4 weeks by 50 micrograms until your thyroxine levels are correct. Your final daily dose may be up to 100-200 micrograms daily.

Patients over 50 years of age:
The recommended starting dose will be no more than 50 micrograms every day. The dose may then be increased by 50 micrograms every 3-4 weeks until your thyroxine levels are correct. Your final daily dose will be between 50-200 micrograms daily.

Patients over 50 years of age with heart problems:
The starting dose will be 25 micrograms every day or 50 micrograms every other day. The dose may be increased by 25 micrograms every 4 weeks until your thyroxine levels are correct. Your final daily dose will usually be between 50-200 micrograms daily.

Use in children and adolescents:
For young children, your doctor is likely to prescribe Levothyroxine Oral Solution instead of tablets.

Congenital hypothyroidism in infants:
This is a condition where your baby has been born with a thyroid gland that does not produce enough thyroxine. The starting dose is 10 -15 micrograms/kg bodyweight per day for the first three months. The dose will then be adjusted depending on how your baby responds to the treatment.

Acquired hypothyroidism in children:
This is a condition where your child?s thyroid gland stops working properly because it has been attacked by their immune system, e.g. in children with an autoimmune disease or following a viral infection. The starting dose is 12.5 ? 50 micrograms per day. The dose will then be increased every 2-4 weeks depending on how your child responds to the medicine.

Juvenile myxoedema:
This is a condition where children and adolescents develop severe hypothyroidism (produce very low levels of thyroid hormones). The starting dose is 25 micrograms every day. The dose will then be increased by 25 micrograms every 2-4 weeks until your child shows mild symptoms of hyperthyroidism (a condition where the thyroid gland produces too much thyroxine). The dose will then be reduced slightly.

If you take more Levothyroxine tablets than you should:
If you (or someone else) swallow a lot of the tablets at the same time, or you think a child may have swallowed some, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose may include: fever, chest pain (angina), racing or irregular heartbeat, muscle cramps, headache, restlessness, flushing, sweating and diarrhoea. These signs can take up to 5 days to appear. Take any remaining tablets and this leaflet with you so that the medical staff knows exactly what you have taken.

If you forget to take Levothyroxine Tablets:
If you forget to take a dose take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose. If you forget to give your child their dose, contact your doctor or pharmacist for further advice.

If you stop taking Levothyroxine Tablets:
These tablets are for long term use. You may need to take them for the rest of your life. Do not stop taking the tablets unless your doctor has told you to do so.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4 POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the tablets and go to hospital at once if you have:
? a rare allergic reaction such as swelling of the face, tongue, lips and throat, difficulty breathing, severe itching of your skin with raised lumps, joint pain, sensitivity to the sun, general feeling of being unwell. You may need urgent medical attention.

Some patients may experience a severe reaction to high levels of thyroid hormone. This is called a “thyroid crisis” and you should contact your doctor immediately if you have any of the following symptoms:
? very high temperature; fast heart rate; irregular heartbeat; low blood pressure; heart failure; jaundice; confusion; fits and coma.

Tell your doctor or pharmacist if any of the following side effects continue, get worse or if you notice any other side effects not listed.

Most of the side effects are similar to the symptoms of hyperthyroidism (where the thyroid gland makes too much thyroxine) and are due to your dose of the medicine being too high. They will usually disappear after reducing the dose or stopping the tablets. However, you must not change the dose or stop the tablets without talking to your doctor first.

Not known (frequency cannot be estimated from the available data)
? headache
? flushing
? high temperature, sweating
? weight loss
? tremor, restlessness, excitability, difficulty sleeping (insomnia)
? increased pressure around the brain in children that is not caused by a tumour or other diseases (benign intracranial hypertension)
? chest pain (angina), pounding, irregular or fast heartbeat
? diarrhoea, vomiting
? muscle cramps, muscle weakness
? deformity of the skull in infants caused by the early closure of joints in the skull bone (craniostenosis)
? growth in children may slow or stop due to changes in bone growth
? irregular periods
? intolerance to heat
? temporary hair loss in children.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5 HOW TO STORELEVOTHYROXINE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25?C. Store in the original package in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Levothyroxine contains
– The active substance is anhydrous levothyroxine sodium.

a) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP ??25mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

b) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 50mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

c) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 100mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.

d) Each tablet contains:
Levothyroxine sodium (anhydrous)? IP?? 125mg
(thyroxine sodium tablet)
Excipients??????????????? q.s.
– The other ingredients are sodium citrate, lactose, maize starch, acacia powder and magnesium stearate.

Contents of the pack

The tablets are packed in a blister pack of 28, 56 or 112 tablets and polypropylene containers of 28, 56, 100, 112 or 1000 tablets. Not all pack sizes may be marketed.

?7. Manufactured in India By:
TAJ PHARMACEUTICALS LIMITED
Mumbai, India
at SURVEY NO. 188/1, 190/1TO 4, ATHIYAWAD , DABHEL,
DAMAN- 396210 (INDIA)

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